FDA Commissioner Stephen Hahn, MD, said Dec. 11 that following an endorsement of Pfizer's COVID-19 vaccine from the agency's vaccine advisory committee, it is working "rapidly" to finalize and issue an emergency use authorization for the vaccine.
Dr. Hahn said the FDA has informed Pfizer about its intent to issue an EUA soon and has also notified the CDC and Operation Warp Speed, the White House's initiative to speed COVID-19 vaccine and drug development, so they can execute their plans to distribute the vaccine.
The FDA's Vaccines and Related Biological Products Advisory Committee voted Dec. 10 to recommend the agency grant an EUA to Pfizer's COVID-19 vaccine candidate. The agency previously said that it plans to distribute the first doses within 24 hours of issuing an EUA.